Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome

Non-melanomatous Skin Cancer Clinical Trial

Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome

Status Completed

Clinical Trial Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the development of basal cell carcinoma.

PURPOSE: Randomized phase II trial to determine the effectiveness of celecoxib in preventing basal cell carcinoma in patients who have basal cell nevus syndrome.

Clinical Trial Description

OBJECTIVES:

• Determine whether celecoxib prevents the development of basal cell carcinoma in patients with basal cell nevus syndrome.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 arms.

• Arm I: Patients receive oral celecoxib twice daily.

• Arm II: Patients receive oral placebo twice daily. Treatment continues for 2 years in the absence of unacceptable toxicity.

Patients are followed every 3 months for 3 years.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study. ;

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Basal Cell Nevus Syndrome
• Carcinoma, Basal Cell
• Non-melanomatous Skin Cancer

• NCT number: NCT00023621
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: February 2001
• Completion date: July 2007